Observational RegIstry of Effectiveness and Safety of teNecTeplase in reAl worLd Settings in China

NCT07271342 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Tiantan Hospital

Phase

Observational

Started

2025-11-30

Last updated

2026-01-06

Condition(s) studied

Stroke

Investigational drug(s) / intervention(s)

tenecteplase

tenecteplase: Intravenous administration of tenecteplase at a single weight-based dose of 0.25 mg/kg (maximum 25 mg), delivered as an intravenous bolus over 5-10 seconds as part of routine clinical care for acute ischemic stroke. Tenecteplase is used as the sole thrombolytic agent in this observational cohort and is not compared against alteplase or any other active control.

Study summary

The ORIENTAL study is a prospective, multicenter, continuously enrolled real-world cohort designed to evaluate the effectiveness and safety of intravenous tenecteplase for acute ischemic stroke (AIS) in routine clinical practice across China. Approximately 10,000 patients from about 200 hospitals will be included. Eligible adults with imaging-confirmed AIS who receive tenecteplase as part of standard care will be consecutively enrolled and followed through 90 days. The study will describe patient characteristics, treatment processes, functional outcomes, and safety events, and will also explore inter-hospital variability and subgroup differences to support quality improvement and guide nationwide implementation of tenecteplase therapy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Adults aged 18 years or older; 2. Diagnosed with acute ischemic stroke confirmed by imaging (CT or MRI); 3. Treated with intravenous tenecteplase at the participating institution; 4. Provided written informed consent, signed by the patient or their legally authorized representative; 5. Capable of completing follow-up assessments. Exclusion Criteria: 1. Received reperfusion therapy prior to the hospital admission (e.g., intravenous thrombolysis prior to admission); 2. Participating in any clinical trials where the intervention may affect the outcomes of this study.

Primary outcome measure(s)

Favorable functional outcome at 90 days (modified Rankin Scale [mRS] score ≤1) — 90 days

Trial sites (1)

Facility	City	Region	Status
Beijing Tiantan Hospital, Capital Medical University	Beijing	China	Recruiting

More Beijing Tiantan Hospital trials in China

Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery Recruiting

Changes in Ciprofol Dosage in Patients With Insomnia Undergoing Intravenous Anesthesia Recruiting

Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma Active, not recruiting

PTCs-based Precision Treatment Strategy on Recurrent High-grade Gliomas Active, not recruiting

Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ Recruiting

Other trials for the same condition

A Functional Near- Infrared Spectroscopy Study on the Brain Activation Characteristics of Stroke Patients During Mirror Movement Recruiting

Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation Recruiting

Using Left Atrium Appendage Closure in NVAF Patients With High Risk of Ischemic Stroke Active, not recruiting

Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management Recruiting

Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07271342 on ClinicalTrials.gov ↗ ← All trials in China